System and method of monitoring for and reporting on patient-made stimulation therapy programming changes

ABSTRACT

A programmer is configured to effect communication with, and programming of, an implantable medical device configured to deliver neurostimulation therapy. The programmer comprises a display, such as touch screen display, and a processor comprising memory and coupled to the display. An interface is coupled to the processor and configured to receive therapy settings data indicative of current therapy settings operative in the implantable medical device and any modifications made to the therapy settings by a patient. The processor is configured to determine if one or more therapy settings have been modified since the last interaction with the patient, and coordinate displaying of the current therapy settings, the one or more therapy settings modified by the patient, and a previous state of the one or more therapy settings modified by the patient on the display.

SUMMARY

Embodiments are directed to a programmer configured to effectcommunication with, and programming of, an implantable medical deviceconfigured to deliver neurostimulation therapy. The programmer comprisesa display, such as touch screen display, and a processor comprisingmemory and coupled to the display. An interface is coupled to theprocessor and configured to receive therapy settings data indicative ofcurrent therapy settings operative in the implantable medical device andany modifications made to the therapy settings by a patient. Theprocessor is configured to determine if one or more therapy settingshave been modified since the last interaction with the patient, andcoordinate displaying of the current therapy settings, the one or moretherapy settings modified by the patient, and a previous state of theone or more therapy settings modified by the patient on the display.

Other embodiments are directed to a programmer configured to effectcommunication with, and programming of, an implantable medical deviceconfigured to deliver neurostimulation therapy. The programmer comprisesa display, such as touch screen display, and a processor comprisingmemory and coupled to the display. An interface is coupled to theprocessor and configured to receive therapy settings data indicative ofcurrent therapy settings operative in the implantable medical device andany modifications made to the therapy settings by a patient. Theinterface is further configured to receive usage data indicating aduration of therapy delivered to the patient over a specified span oftime. The processor is configured to determine if one or more therapysettings have been modified since the last interaction with the patient,and coordinate displaying of the current therapy settings, the one ormore therapy settings modified by the patient, a previous state of theone or more therapy settings modified by the patient on the display, andthe usage data on the display.

Further embodiments are directed to a method comprising receiving, at aprogrammer, therapy settings data acquired from an implantable medicaldevice configured to deliver neurostimulation therapy. The therapysettings data comprises data indicative of current therapy settingsoperative in the implantable medical device and any modifications madeto the therapy settings by a patient. The method also comprisesdetermining, by the programmer, if one or more therapy settings havebeen modified by the patient. The method further comprises displaying,on a display of the programmer, the current therapy settings, the one ormore therapy settings modified by the patient, and a previous state ofthe one or more therapy settings modified by the patient.

The above summary is not intended to describe each disclosed embodimentor every implementation of the present disclosure. The figures and thedetailed description below more particularly exemplify illustrativeembodiments

BRIEF DESCRIPTION OF THE DRAWINGS

Throughout the specification reference is made to the appended drawings,where like reference numerals designate like elements, and wherein:

FIG. 1 shows apparatuses for effecting communication with an implantablemedical device (IMD) in accordance with various embodiments;

FIG. 2 is an illustration of a clinic or hospital equipped to monitor apatient during a medical evaluation, such as a sleep study fordetermining whether the patient is suffering from a sleep disorder, inaccordance with various embodiments;

FIG. 3 illustrates an apparatus for effecting communication with an IMDin accordance with various embodiments;

FIG. 4 illustrates an apparatus for effecting communication with an IMDin accordance with various embodiments;

FIGS. 5A and 5B illustrate front and rear views of a patient remote inaccordance with various embodiments;

FIG. 6 shows a patient remote with its front cover removed in accordancewith various embodiments;

FIG. 7 illustrates various processes for adjusting therapy parameters ofan implantable medical device using a patient remote in accordance withvarious embodiments;

FIGS. 8 and 9 illustrate methods for presenting patient modified therapyparameters in a conspicuous manner on a programmer communicativelycoupled to the implantable medical device in accordance with variousembodiments;

FIG. 10 shows a representative patient remote configured to facilitatepatient adjustment of up to three different therapy parameters, shown asparameters A, B, and C in accordance with various embodiments;

FIG. 11 is a chart of representative information about each of the threeparameters A, B, and C shown in FIG. 10 that can be monitored, stored,and subsequently evaluated by a clinician in accordance with variousembodiments;

FIG. 12 illustrates each of the representative parameters A, B, and C ofFIGS. 10 and 11 superimposed on an illustrative stimulation waveform inaccordance with various embodiments;

FIG. 13 illustrates a patient remote which includes control buttons foradjusting a number of different therapy parameters in accordance withvarious embodiments;

FIG. 14 shows a representative neurostimulation apparatus which includesan implantable neurostimulator electrically coupled to a stimulationlead in accordance with various embodiments;

FIG. 15 shows the various electrode configurations or vectors for thestimulation lead shown in FIG. 14 that can be selected in accordancewith various embodiments;

FIG. 16 illustrates various activities associated with deliveringneurostimulation therapy for treating obstructive sleep apnea inaccordance with various embodiments;

FIG. 17 is a screen of an application interface provided on a display ofa programmer showing various therapy parameters of an implantablemedical device, such as a neurostimulator, that can be adjusted by aclinician in accordance with various embodiments;

FIG. 18 is a screen of an application interface showing various therapysettings on a display of a programmer in accordance with variousembodiments;

FIG. 19 shows various settings that can be adjusted by a clinician,including stimulation amplitude and limits that define apatient-controllable stimulation amplitude range in accordance withvarious embodiments;

FIG. 20 is a screen of an application interface showing informationconcerning a multiplicity of programming sessions conducted over thecourse of a single day in accordance with various embodiments;

FIG. 21 is a screen of an application interface showing a summary reportthat provides a clear indication of the initial and final states of anytherapy setting that was modified between the first and last programmingsessions of a multi-programming session sleep study in accordance withvarious embodiments; and

FIG. 22 is a representative display of information presented in a sleeplog format that communicates the time and duration of therapy for eachday.

The figures are not necessarily to scale. Like numbers used in thefigures refer to like components. However, it will be understood thatthe use of a number to refer to a component in a given figure is notintended to limit the component in another figure labeled with the samenumber.

DETAILED DESCRIPTION

In the following description, reference is made to the accompanying setof drawings that form a part of the description hereof and in which areshown by way of illustration several specific embodiments. It is to beunderstood that other embodiments are contemplated and may be madewithout departing from the scope of the present disclosure. Thefollowing detailed description, therefore, is not to be taken in alimiting sense.

Unless otherwise indicated, all numbers expressing feature sizes,amounts, and physical properties used in the specification and claimsare to be understood as being modified in all instances by the term“about.” Accordingly, unless indicated to the contrary, the numericalparameters set forth in the foregoing specification and attached claimsare approximations that can vary depending upon the desired propertiessought to be obtained by those skilled in the art utilizing theteachings disclosed herein. The use of numerical ranges by endpointsincludes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2,2.75, 3, 3.80, 4, and 5) and any range within that range.

Embodiments of the present disclosure are directed to an apparatus andmethod for monitoring for patient modification of one or more therapysettings of an implantable medical device and reporting any such patientmodifications in a manner that is readily perceivable via a programmer.Other embodiments are directed to an apparatus and method for monitoringfor patient modification and automatic (i.e., algorithmic)device-initiated modification of one or more therapy settings of animplantable medical device and reporting any such patient and automateddevice-initiated modifications in a manner that is readily perceivablevia a programmer. In some embodiments, the programmer is a wirelessprogrammer, such as a tablet configured to implement an application orbrowser. In other embodiments, the programmer may have a wiredcommunications interface and be configured to implement an applicationor browser and communicate with an IMD via a multiplicity ofcommunication links which can include one or more wireless communicationlinks and/or one or more wired communication links.

FIG. 1 shows apparatuses for monitoring for patient modification of oneor more therapy settings of an implantable medical device and reportingany such patient modifications in a manner that is readily perceivable.Some embodiments are directed to a wireless programmer, while others aredirected to a wired programmer. For purposes of illustration and not oflimitation, the following discussion primarily refers to a wirelessprogrammer, it being understood that the embodiments disclosed hereincan employ a wired programmer. The term wireless refers to acommunication connection that includes at least one wireless link,although the communication connection can also include a wired link.FIG. 1 shows a wireless programmer 102 configured to communicate with atelemetry cable 150. According to various embodiments, the wirelessprogrammer 102 can be implemented as a tablet computer or other mobilecomputing device (e.g., a notebook or laptop). The wireless programmer102 is configured to implement an application (also referred to as an“app”) or a browser that facilitates clinician interaction with thetelemetry cable 150 and the IMD. The wireless programmer 102 can be usedby a clinician to interrogate an IMD and make adjustments to variousparameters of an IMD (referred to as “programming” the IMD), monitortherapy delivered by the IMD, and monitor patient adherence toprescribed therapy. FIG. 1 also shows a patient remote 180 configured tofacilitate patient adjustment of one or more therapy settings of the IMDdirectly (i.e., without the need of programmer 102).

The telemetry cable 150 communicates wirelessly with the IMD andfacilitates wireless communication between the IMD and the wirelessprogrammer 102. Generally, each wireless programmer 102 is uniquelypaired to a particular telemetry cable 150, and each wireless programmer102 works only with its uniquely paired telemetry cable 150. In someembodiments, a generic portable computing device (e.g., a tablet orlaptop) can be configured by software to serve as an “app-based”programmer, and can operate as a stand-alone programmer or incooperation with a desktop or stationary programmer (e.g., PCprogrammer). App-based programmers can be uniquely paired to aparticular telemetry cable at any given moment, but this pairingrelationship can be changed on-the-fly as a sleep technician moves fromhis or her PC terminal to a tablet and for utilization by remote supportindividuals.

The wireless programmer 102 includes a display 104 and a stylus 106which allows the clinician to interact with the display 104, such as byinputting, modifying, and reviewing data. The stylus 106 may be a doublesided device, so that either the pen tip or the eraser site may be used.The stylus 106 is shown tethered to the programmer 102 via a cable 108,which provides signaling and power to the stylus 106. Alternatively, thestylus 106 may be a wireless device with its own power source, such as abattery. In some embodiments, the display 104 can be configured as atouchscreen, in which case the stylus 106 may be excluded or an optionalaccessory. A handle 103 is provided in the upper portion of theprogrammer 102, and a recessed section of the programmer housing 101above or below the handle 103 can be used to store the stylus 106 whennot in use.

The wireless programmer 102 includes a number of interfaces, buttons,and controls, several of which are shown in the illustrative embodimentof FIG. 1. A power button 110 is provided on an upper right edge of thehousing 101, and a cluster of controls 130 is provided on an upper rightportion of the front surface of the housing 102. The control cluster 130includes a multi-position control 132 that allows the clinician tointeract with a processor 107 and display 104 of the programmer 102 invarious ways. The processor 107 of the programmer 102 can be programmedto implement the various processes and functions described herein.Additional buttons 134 can be situated proximate (or apart from) thecontrol cluster 130. For example, the control cluster 130 and additionalbuttons 134 can allow the clinician to select between differentoperating modes and/or various user-assignable or emergency-offfunctions (e.g., places the IMD into a known safe state or performslive-saving functions). The wireless programmer 102 includes a number ofdifferent interfaces/components including a power connector plus USBport 118 and a network cable and USB port 120. The interfaces andcomponents listed above are for purposes of illustration, not oflimitation.

The telemetry cable 150 is configured to wirelessly communicate withboth the wireless programmer 102 and an IMD. The telemetry cable 150effectively serves as a wireless bridge or modem between the programmer102 and the IMD. The telemetry cable 150 comprises disparatecommunication devices that together support a communication channelcomprising disparate sequential communication links configured tofacilitate bidirectional communication between the IMD and the wirelessprogrammer 102. In particular, the telemetry cable 150 provides forbi-directional communication with the IMD and bi-directionalcommunication with the wireless programmer 102. According to variousembodiments, the wireless programmer 102 monitors for establishment of,and loss of connectivity with, each of the disparate communication linksthat define the hybrid communication channel. In some embodiments, thetelemetry cable 150 is configured to self-monitor its connectivity withthe wireless programmer 102 and to indicate a status of saidconnectivity. In some embodiments, the telemetry cable 150 is configuredto deliver power to the IMD in addition to communicating with it (e.g.,via inductive coupling). The IMD may use the wireless power to operate aportion or all of its functions or to recharge the IMD battery orcapacitor.

In accordance with the embodiment shown in FIG. 1, the telemetry cable150 includes a telemetry head 152 configured to wirelessly communicatewith the IMD via a near-field link. The telemetry head 152 is shown toinclude a status indicator 153, such as an LED indicator. The telemetryhead 152 can be configured to self-monitor establishment and loss ofconnectivity with the wireless programmer 102. Alternatively, or inaddition, the telemetry head 152 can be configured to self-monitorestablishment and loss of connectivity with the IMD. For example, thestatus indicator 153 can be illuminated with a green color to indicategood signaling between the telemetry head 152 and the IMD. The statusindicator 153 can be illuminated with an orange color to indicate pooror no signaling between the telemetry head 152 and the IMD.

In some embodiments, the telemetry head 152 is configured to inductivelycommunicate with the IMD via a near-field link. A near-field linkappropriate for effecting communications with an IMD typically has arange of about 5 centimeters. A typical inductive near-field linkbetween the telemetry head 152 is highly directional, operates safelythrough human tissue, and is susceptible to electrical noise. Inaddition to being extremely short range, inductive telemetrycommunication is low-power and does not interfere with medical orcommunication equipment. However, inductive telemetry signals aresusceptible to electrical noise, such as from hospital beds, smartphones, tube monitors/TVs, power supplies, respiratory inductiveplethysmography (RIP), RIP belts, the RIP box, PSG wires, and the headbox, for example. In some embodiments, an alternative to near-fieldinductive communication can be implemented, including: e-fieldcommunications (MICS, ISM), and medium range induction technology whichutilizes advanced amplifiers and transmitters to achieve ranges of up to1 m. It is noted that the use of multiple coils, such as in three-axesimplementations, can eliminate the directionality issue with inductivelinks.

A cable 154 extends from the telemetry head 152 and is connected to awireless transceiver 160. The wireless transceiver 160 may be configuredfor short-range radio frequency (RF) communication. For example, thewireless transceiver 160 may be configured to implement a short-range RFcommunication link, such as by implementing a Bluetooth®(short-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)or ZigBee® (radio waves in ISM radio bands: 868 MHz in Europe, 915 MHzin the USA and Australia, and 2.4 GHz in most jurisdictions worldwide)communications protocol. In some embodiments, the wireless transceiver160 can be configured to wirelessly communicate with existing networkinfrastructure via an appropriate RF communication protocol, such asWi-Fi® (also considered a short-range RF communication link of up toabout 45 meters indoors). In such embodiments, a hybrid communicationlink can be established between the IMD and the wireless programmer 102using a wireless local area network (WLAN) via a wireless networkconnection for increasing the wireless communication range of thetelemetry cable 150.

The wireless transceiver 160 typically has a range significantly greaterthan that of the link established by the telemetry head 152 (e.g., onthe order of at least a magnitude difference). For example, the wirelesstransceiver 160 may have a range of about 5-20 meters. In contrast tothe near-field link described above, a typical wireless link establishedbetween the wireless transceiver 160 and wireless programmer 102 is notdirectional and is blocked by human tissue. Moreover, a wirelesstransceiver 160 implemented according to a Bluetooth® protocol operatesat the same frequencies as Wi-Fi® and is ubiquitous and safe for use inhospitals and care facilities.

The wireless transceiver 160 is shown to include a status indicator 162.The wireless transceiver 160 can be configured to self-monitorestablishment and loss of connectivity with the wireless programmer 102.Alternatively, or in addition, the wireless transceiver 160 can beconfigured to self-monitor establishment and loss of connectivity withthe telemetry head 152. In some implementations, the status indicator162 includes an LED, which indicates a good or nominal operating statusby way of constant LED illumination. The status indicator 162 may blinkor be extinguished to indicate a poor or non-operating status of thewireless transceiver 160. Power is supplied to the telemetry cable 150by way of a power supply 170, which is shown to include a power cable172 terminated by a standard AC wall plug 174. The power supply 170provides power for both the wireless transceiver 160 and the telemetryhead 152.

The wireless remote 180 is shown to include buttons to allow the patientto modify therapy parameters, and status indicators for implantabledevice status (e.g., remote and implantable device communication statusand implantable device battery status) and remote status (remote batterystatus). The wireless remote 180 is utilized by a patient during homeuse of the therapy and to make necessary adjustments of therapyparameters if needed or desired.

FIG. 2 is an illustration of clinic or hospital rooms equipped tomonitor a patient 225 during a medical evaluation, such as a sleep studyfor determining whether the patient is suffering from a sleep disorder.In this illustrative embodiment, a neurostimulator 280 (see also FIG.2A) has been implanted in the patient 225 in the subclavian region forpurposes of treating obstructive sleep apnea. Obstructive sleep apnea isa common disorder, characterized by recurrent narrowing and closure ofthe upper airway accompanied by intermittent oxyhemoglobin desaturationand sympathetic activation. The onset of apnea is accompanied by areduction in drive to the upper-airway muscles, and upper-airway patencyis strongly correlated with the activation of the genioglossus muscle.Upper-airway stimulation with the use of unilateral stimulation of thehypoglossal nerve, synchronous with ventilation, is a viable treatmentoption, providing significant and clinically meaningful reductions inthe severity of obstructive sleep apnea and self-reported sleepiness andimprovements in quality-of-life measures.

The neurostimulator 280 shown in FIG. 2 includes a stimulation lead 282that extends from the housing of the neurostimulator 280 to thehypoglossal nerve in the patient's neck. A sensing lead 284 extends fromthe housing of the neurostimulator 280 and is implanted at anintercostal muscle location of the rib cage. The sensing lead 284detects intercostal muscle movement during patient respiration, signalsfrom which are used to detect patient respiration. A pulse generator inthe neurostimulator 280 provides electrical stimulation to thehypoglossal nerve via the stimulation lead 282 based on detected patientrespiration.

In the illustrative testing environment shown in FIG. 2, the patient 225is shown lying down on a bed 227 in a patient room 220 for purposes ofconducting a sleep study. The patient room 220 may be configured anddecorated much like a typical motel room to simulate a restful bedroomenvironment. FIG. 2 also shows a clinician room 200 which is typically aseparate room adjacent to or near the patient room 220. The clinicianroom 200 is typically close to the patient room 220 to facilitateefficient evaluation of, and communication with, the patient 225 duringthe sleep study. Importantly, the clinician room 200 is separated by awall or other privacy structure that provides a measure of privacy andsecurity for the patient 225 during the sleep study. Although thepresence of a walled structure between the clinician and patient rooms200 and 220 advances the objective of enhancing the sleep environmentfor the patient's benefit, the walled structure presents a physicalbarrier between diagnostic equipment distributed between the physicallyseparate clinician and patient rooms 200 and 220.

In the illustrative embodiment shown in FIG. 2, a patient system 221 issituated in the patient room 220 and a clinician system 201 is situatedin the clinician room 200. The patient system 221 includes a telemetrycable 250 positioned proximate the patient 225, and includes a telemetryhead 252 communicatively coupled to a wireless transceiver 260. Thepatient system 221 may also include a patient remote (not shown) thatenables the patient to modify one or more therapy settings of the IMD.Although a patient remote is a component of the system illustrated inFIG. 2, the patient remote may be excluded from the sleep study/therapytitration scenario represented in FIG. 2. The telemetry cable 250 isconnected to a power supply 270 via a power cable 272. The power supply270 is shown connected to a AC power strip 274 which, in turn, iselectrically connected to a standard AC wall socket 276. The cliniciansystem 201 includes a wireless programmer 202, which is shown resting ona work desk within the clinician room 200. A computer system 208 andother equipment may be provided in the clinician room 200. The wirelessprogrammer 202 situated within the clinician room 200 is communicativelycoupled to the neurostimulator 280 via the telemetry cable 250. Thewireless programmer 202 can be used by a clinician to interact with theneurostimulator 280 without disturbing the patient's sleep, which isimportant for conducting productive sleep studies.

FIG. 3 illustrates an apparatus for monitoring for patient modificationof one or more therapy settings of an IMD and reporting any such patientmodifications in a manner that is readily perceivable in accordance withvarious embodiments. In the embodiment illustrated in FIG. 3, theapparatus 300 includes a wireless programmer 302 configured tocommunicate with an IMD 360, such as a neurostimulator for treatingobstructive sleep apnea, via a wireless communication channel comprisingdisparate communication links, including a wireless link 323 and anear-field link 362. The wireless programmer 302 is illustrated as acomponent of the clinician system 301 that can be operated from a roomadjacent to or near a room within which a patient system 331 issituated. The patient system 331 includes a patient remote 380configured to facilitate patient adjustment of one or more therapysettings of the IMD directly (i.e., without the need of programmer 302)via a wireless communication link 382. The patient system 331 furtherincludes a telemetry cable 330 having a telemetry head 332communicatively coupled to a wireless transceiver 340, such as aBluetooth® or ZigBee® transceiver. The telemetry head 332 communicateswith the IMD 360 via a separate wireless link, shown as a near-fieldlink 362. In some implementations, the near-field link 362 can be aninductive communication link.

In one implementation, a wired link 333 communicatively couples thetelemetry head 332 with the wireless transceiver 340. In otherimplementations, a wireless link 334 can be implemented tocommunicatively couple the telemetry head 332 with the wirelesstransceiver 340. The telemetry head 332 can include a status indicator336, which provides a visual indication of the operating status of thetelemetry head 332. The telemetry head 332 can include a user controlfacility 335 to allow user adjustment of one or more telemetry devicefunctions. According to some embodiments, the user control facility 335allows the clinician to control basic operations of the telemetry device332 without need of the full programmer interface. Utilization of thesecontrols 335 includes allowing a clinician quick access to basiccontrols of the telemetry device 332 when in the patient's room, as wellas allowing the same control of the telemetry device 332 by the patientin some embodiments. For example, the user control facility 335 mayinclude a number of control buttons (e.g., buttons a-n) that areactuatable by the clinician and control various basic operations of thetelemetry device 332. Button 335-a, for example, can be an on/off switchthat respectively enables and disables manual adjustment of one or morefunctions of the telemetry device 332. Button 335-b can be a variablerocker switch that allows the clinician to gradually (e.g., step-wise)increase and decrease the strength of the wireless (e.g., inductive)link between the telemetry device 332 and the implantable medical device360. Button 335-n can be a switch that initiates a self-diagnostic testthat assesses the present ability of the telemetry device 332 tocommunicatively interface with the IMD 360. Other buttons may beprovided to effectuate desired operations and/or functionality. Forexample, button 335-n can be an emergency button that places the IMD 360into a known safe mode or causes the IMD 360 to perform a life-savingfunction. The emergency button 335-n may, for example, turn aneurostimulator off, return a pacemaker to a basic mode, or disable adefibrillation capability of an ICD (implantablecardioverter/defibrillator).

The wireless transceiver 340 can include a status indicator 342, whichprovides a visual indication of the operating status of the transceiver340. A power source 350 is shown coupled to the wireless transceiver 340via a wired power cable 352. The power source 350 provides power to boththe wireless transceiver 340, via the power cable 352, and to thetelemetry head 332, via the wired link 333. In some implementations, thepower source 350 is configured to connect with a standard AC wallsocket. In other implementations, the power source 350 may be a batteryor other self-contained power source. In implementations that use awireless link 334 between the telemetry head 332 and wirelesstransceiver 340, the telemetry head 332 may include its own powersource, such as a battery.

FIG. 4 illustrates an apparatus for monitoring for patient modificationof one or more therapy settings of an IMD and reporting any such patientmodifications in a manner that is readily perceivable in accordance withother embodiments. In the embodiment illustrated in FIG. 4, theapparatus 400 includes a wireless programmer 402 configured tocommunicate with an IMD 460 (e.g., a neurostimulator for treatingobstructive sleep apnea) via a wireless communication channel comprisingdisparate communication links, including a wireless link 423 and anear-field link 462. The wireless programmer 402 is illustrated as acomponent of the clinician system 401 that can be operated from a roomadjacent to or near a room within which a patient system 431 issituated. In the embodiment shown in FIG. 4, the patient system 431includes a patient remote 480 configured to facilitate patientadjustment of one or more therapy settings of the IMD 460 directly(i.e., without the need of programmer 402) via a wireless communicationlink 482. The patient system 431 also includes a telemetry device orapparatus 400 configured to wirelessly communicate with both thewireless programmer 402 and the IMD 460 using different wirelesscommunication links. The telemetry device 400 shown in FIG. 4 integratesinto a single device a telemetry transceiver 432 and a wirelesstransceiver 440.

The telemetry transceiver 432 is configured to establish a near-fieldwireless link 462 with the IMD 460. The wireless transceiver 440 isconfigured to establish a short range RF communication link with thewireless programmer 402 (e.g., via a Bluetooth® or ZigBee® protocol).The wireless transceiver 440 is communicatively coupled to the telemetrytransceiver 432 via a signaling channel 434. In one implementation, apower connection 436 couples power supplied by a power source 450 fromthe wireless transceiver 440 to the telemetry transceiver 432. Inanother implementation, the power source 450 supplies power to thewireless transceiver 440 and the telemetry transceiver 432 individually.According to some embodiments, the telemetry transceiver 432 and thewireless transceiver 440 constitute discrete components of the telemetrydevice 400. In other embodiments, the telemetry transceiver 432 and thewireless transceiver 440 are implemented as components of a commonintegrated circuit or otherwise populating a common printed circuitboard, with conductive traces provided for communicating data signalsand power thereto and/or therebetween.

The telemetry device or apparatus 400 can include a user controlfacility 435 to allow user adjustment of one or more telemetry devicefunctions. According to some embodiments, the user control facility 435allows the clinician to control basic operations of the telemetry device432 without need of the full capabilities of the programmer 402. As waspreviously discussed, utilization of these controls 435 includesallowing a clinician quick access to basic controls of the telemetrydevice 432 when in the patient's room, as well as allowing the samecontrol of the telemetry device 432 by the patient in some embodiments.For example, the user control facility 435 may include a number ofcontrol buttons (e.g., buttons a-n) that are actuatable by the clinicianand control various basic operations of the telemetry device 432.Buttons 435-a, 435-b, and 435-n, for example, can have the same ordifferent functionality as described above with reference to controls335 a-n shown in FIG. 3. Other buttons may be provided to effectuatedesired operations and/or functionality.

FIGS. 5A and 5B illustrate front and rear views of a patient remote inaccordance with various embodiments. The patient remote 501 shown inFIG. 5A has a control panel 502 which includes a number of useractuatable control buttons. The control buttons provided on the controlpanel 502 allow the patient to turn therapy on and off, pause therapy,and allow the patient to adjust one or more parameters that affect theoperation of the implantable medical device that is surgically implantedin the patient. The number and type of control buttons provided on thecontrol panel 502 are purposefully few and simple in operation withlimited functionality. In the embodiment of the patient remote 501 shownin FIG. 5A, the control panel 502 includes a therapy ON button 504 and atherapy OFF button 506, which can be actuated to respectively turn onand off stimulation therapy by the patient. The control panel 502further includes an increase control 510, which allows the patient toincrease stimulation strength within a range selected by the clinician.A decrease control 512 provided on the control panel 501 allows thepatient to decrease the stimulation strength within a range pre-selectedby the clinician.

According to some embodiments, the patient remote 501 includes a beeper514, which provides audio feedback to the patient while performingpatient programming of the implanted medical device. In otherembodiments, the patient remote 501 includes one or both of a microphone503 and an oximetry sensor 505. Although shown on the front cover of thepatient remote 501, the oximetry sensor 505 can be situated elsewhere onthe patient remote 501 (e.g., on the rear or side exterior surface or aninterior surface exposed by removal of the front cover). The microphone503 can also be mounted elsewhere on the patient remote 501. Themicrophone 503 can be used to detect respiratory noise, such as snoring,which can be analyzed by circuitry within the patient remote 501. Forexample, the circuitry can be configured to determine maximum nocturnalsound intensity (dBmax) and/or to produce a snoring index (SI) (i.e.,the number of snores per hour of sleep). The oximetry sensor 505 can beconfigured to facilitate pulse oximetry on a patient's finger that isplaced on the sensor 505. Circuitry within the patient remote 501 can beconfigured to determine the patient's oxygen saturation. The circuitycan also be configured to calculate the oxygen desaturation index or ODIof the patient, by calculating the number of times per hour of sleepthat the patient's blood oxygen level drops by 3 percent or more frombaseline. Respiratory noise and/or oximetry (e.g., ODI) data can be usedto assess effectiveness of therapy setting changes made by the patientor automatically. The patient remote 501 may also include anaccelerometer or motion sensor (not shown), and circuitry can beconfigured to detect and monitor patient movement during sleep. Alsoshown along a lower peripheral edge of the patient remote 501 is arelease button 516, which allows access to an interior compartment ofthe patient remote that houses a battery. A wrist strap attachment 518allows for the addition of a convenient wrist strap to enhanceportability of the patient remote 501.

FIG. 5B shows a rear surface of the patient remote 501, which includesvarious types of information useful to the patient as well as a numberof illuminatable indicators. Among the various types of informationprovided on the rear surface of the patient remote 501 is anillustration of a target 507. The target 507 indicates the location ofthe patient remote 501 to be positioned above the IMD surgicallyimplanted within the patient when communicating. The various indicatorsinclude a therapy ON indicator 522, which illuminates in green toindicate that therapy is presently on. A therapy OFF indicator 528illuminates in yellow to indicate that therapy is presently off.Typically, the therapy OFF indicator 528 turns on after the patientpresses a button on the control panel 502 other than the therapy ONbutton 504. In some cases, neither the therapy ON or therapy OFFindicators 522 and 528 turn on after pressing any button. In such cases,this indicates that the patient remote 501 did not communicate with theIMD.

In the embodiment shown in FIG. 5B, a stimulator battery statusindicator 524 becomes illuminated in various ways to communicatedifferent information after any control button on the control panel 502is pressed. For example, the stimulator battery status indicator 524illuminates green (constant illumination) to indicate that the batteryof the IMD is good. When the stimulator battery is low, the greenstimulator battery status indicator 524 blinks after any button on thecontrol panel 502 is pressed. The blinking green indicator 524 indicatesto the patient that a call to the clinician's office is required. Incases where the green stimulator battery status indicator 524 is offafter pressing any button on the control panel 502, this indicates thatthe patient remote 501 did not communicate with the IMD.

The embodiment shown in FIG. 5B includes a battery indicator 526, thestate of which communicates various types of information about thestatus of the patient remote's battery. The battery indicator 526 turnson with constant illumination after any button on the control panel 502is pressed. A constant illumination state of the battery indicator 526indicates that the patient remote 501 is operating properly. When thepatient remote's battery is low, the battery indicator 526 blinks afterany button on the control panel 501 is pressed. If the battery indicator526 is off after pressing any button on the control panel 502, immediatereplacement of the patient remote's battery is required. According tosome embodiments, usage data and therapy settings can allow for moreaccurate predictions of remaining IMD battery life made by theprogrammer or patent remote.

FIG. 6 shows a patient remote 501 with its front cover removed inaccordance with various embodiments. The front cover of the patientremote 501 can be removed by actuation of the release button 516.Removing the front cover allows access an internal compartment 630 thathouses the battery 632, which is typically a 9 V battery. A beeper 514and a beeper control 615 are shown in the compartment 630 underneath thepatient remote's front cover. The beeper 514 includes a speaker anddriver electronics which are coupled to the beeper control 615. Thebeeper control 615 allows the user to adjust the volume of the beeper,such as between three different amplitude states as shown in FIG. 6.Generally, the beeper volume is set too high as a default.

The beeper is used to facilitate patient programming of the IMD andprovides auditory feedback during the programming process. During atargeting mode (i.e., properly positioning the patient remote 501 abovethe IMD), for example, the beeper is used much like a stud finder isused for locating structures within walls, to locate the best positionfor communicating with the IMD. During a targeting mode of operation,the patient presses the therapy OFF button 506 and moves the patientremote 501 in proximity with the IMD that is surgically implanted withinthe patient. The patient continues to hold the therapy OFF button 506while moving the patient remote 501 until a continuous beep from thebeeper 514 is heard. When the beeper transitions from a discontinuousbeep to a continuous beep, the patient has found the best location forprogramming the IMD. The patient may then release the therapy OFF button506, and if desired, turn therapy on again via the therapy ON button504.

The beeper 514 can be used for other procedures, such as when turning onand off therapy via the control buttons 504 and 506, respectively. Whenthe patient wishes to turn on therapy, the patient remote 501 ispositioned over the stimulator and the therapy ON button 504 is pressed.If the beeper volume is on, a beep confirms the programming change. Itis noted that the stimulation turns on with the same stimulationstrength that was set when the patient turned therapy off. When therapyis turned on, the patient will feel one burst of stimulation. Therapy isthen delayed for a set period of time while the patient falls asleep.This delay is called the start delay (or therapy delay). The patient cancheck to see if the therapy ON indicator 522 is constantly illuminated.If the green indicator 522 is constantly illuminated, therapy wassuccessfully turned on. The therapy on indicator 522 remains on forabout six seconds after the therapy ON button 504 is released. Thebeeper 514 is activated when turning therapy off. For example, thepatient can position the patient remote 501 over the IMD, and then pressthe therapy OFF button 506. If the deeper volume is on, a beep confirmsthis programming change. The therapy OFF indicator 528 should now beilluminated on the back of the patient remote 501. If the yellowindicator 528 is on, the therapy was successfully turned off. Thisindicator 528 remains on for about six seconds after the therapy OFFbutton 506 is released.

The increase and decrease stimulation buttons 510 and 512 of the controlpanel 502 allow the patient to respectively increase and decrease thestimulation strength (amplitude) within a range previously selected(programmed) by the clinician. The strength of hypoglossal stimulation,for example can be modified by the patient within a stimulation rangepre-programmed by the clinician in order to enhance patient comfortwhile providing efficacious therapy to the patient. If stimulation feelstoo strong, the patient may decrease the stimulation strength bypressing the decrease stimulation strength button 512. If no or littlestimulation is felt by the patient, the patient may wish to increase thestimulation strength by pressing the increase stimulation strengthbutton 510.

According to one illustrative patient programming routine, the patientpositions the patient remote 501 over the IMD, and presses the therapyON button 504. It is noted that therapy must be on in order to increasestimulation strength according to various embodiments. The patient mayincrease or decrease stimulation strength by pressing the increase anddecrease stimulation strength buttons 510 and 512, respectively. Toevaluate the stimulation strength adjustment, the patient turns offtherapy using the therapy OFF button 506. The patient then turns ontherapy using the therapy ON button 504. One burst of stimulation isdelivered to the patient when therapy is turned on to indicate therelative strength of the stimulation energy being delivered to thepatient. The beeper 514 beeps once for each successful adjustment. Ifthe patient remote beeps rapidly three times, the patient has reachedthe stimulation strength adjustment limit, which includes both upper andlower limits.

FIG. 7 illustrates various processes for adjusting therapy parameters ofan IMD using a patient remote in accordance with various embodiments.For purposes of illustration and not of limitation, the methodologyshown in FIG. 7 will be described within the context of aneurostimulator device configured to treat obstructive sleep apnea. Itis understood that the processes shown in FIG. 7 and other figures canapply to other IMDs that deliver therapy, such as a cardiac pacemaker,resynchronizer, cardioverter/defibrillator, muscle stimulator or othertype of stimulation device. The method embodiment shown in FIG. 7involves setting 702 therapy parameters of an IMD, such as aneurostimulator, by a clinician after implant/device testing andsubsequent to a healing period, followed by activating theneurostimulator after device testing. The methodology shown in FIG. 7also involves modifying 704 (e.g., titrating) therapy parameters of theneurostimulator by the clinician after activation of the device toreduce (e.g., minimize) occurrence of obstructive events. In addition totitrating the therapy parameters of the neurostimulator, the method ofFIG. 7 involves setting 706 control limits on patient modifiable therapyparameters based on the therapy parameters titrated (i.e., modified) instep 704. The methodology of FIG. 7 further involves adjusting 708therapy parameters within the established control limits by the patientto promote comfort and efficacy of the therapy delivered by theneurostimulator. Adjusting 708 the therapy parameters within the controllimits established by the clinician involves use of a patient remote ofa type described herein.

FIGS. 8 and 9 illustrate methods for presenting patient modified therapyparameters in a conspicuous manner on a programmer communicativelycoupled to the IMD in accordance with various embodiments. In someembodiments, the programmer is configured as a wireless mobileprogrammer of the type described previously herein. In otherembodiments, the programmer may be a stationary programmer, such as oneenabled by a desktop PC or other relatively stationary processingdevice. For purposes of illustration and not of limitation, theembodiment illustrated in FIG. 8 will be described in the context of awireless mobile programmer.

The methodology shown in FIG. 8 involves receiving 802, at a wirelessmobile programmer, therapy settings data comprising data indicative ofcurrent therapy settings operative in an IMD and any modifications madeto the therapy settings by a patient and optionally by the IMD. Themethodology illustrated in FIG. 8 also involves determining 804, by theprogrammer, if one or more therapy settings have been modified by thepatient and optionally by the IMD. The method shown in FIG. 8 furtherinvolves displaying 806 on a display of the programmer (and/orgenerating a report to include) the current therapy settings, the one ormore therapy settings modified by the patient and optionally by the IMD,and a previous state of the one or more therapy settings modified by thepatient and optionally by the IMD. In some embodiments, the method shownin FIG. 8 may involve accentuating 808 presentation of the one or moretherapy settings modified by the patient relative to other therapysettings presented on the display of the programmer and/or in a report.In addition to displaying on the programmer and/or generating a report,the current therapy settings and modification by the patient andoptionally by the IMD can also be saved (e.g., in a report) for outputor download.

The methodology illustrated in FIG. 9 involves receiving 902, at awireless mobile programmer, therapy settings data comprising dataindicative of current therapy settings operative in an IMD and anymodifications made to the therapy settings by a patient and optionallyby the IMD. The method shown in FIG. 9 also involves determining 904, bythe programmer, if one or more therapy settings have been modified bythe patient and optionally by the IMD, and acquiring 906 usage dataindicating a duration of therapy delivered to the patient over aspecified span of time. The usage data can be associated with each setof therapy settings utilized over the specified span of time, so as toreveal which set of therapy settings were used most and the usageresults associated with each.

In some embodiments, the method involves determining 907 theeffectiveness of therapy setting changes made by the patient andoptionally by the IMD, such as by analyzing various data acquired by theIMD and/or the patient remote or other external devices and sensors(e.g., oxygen desaturation index (ODI), apnea-hypopnea index (AHI),snoring index (SI), maximum nocturnal sound intensity, patient motion,etc.). For example, one or more of ODI, snoring, oximetry, nocturnalmotion, and respiratory noise can be collected by the patient remote orother external device and used to determine a useful AHI estimate.Changes in the AHI estimate can be monitored to assess effectiveness oftherapy setting changes made by the patient or automatically.

The processes of blocks 902-907 thus involve determining if one or moretherapy settings have been modified by the patient and optionally by theIMD, acquiring usage data indicating a duration of therapy delivered tothe patient over a specified span of time or times, and theeffectiveness or lack of effectiveness of any such therapy changes.Usage data may be acquired from the patient remote, the patient remotevia a web-based patient management system, another external device orsystem, or from the IMD. In some embodiments, the data acquired by theprogrammer and/or patient remote or other external device, includingusage data, can be downloaded (as data or in report form) via aweb-portal based on data collected and sent to this portal from thepatient remote or the IMD. This content can be identical to what is madeavailable on the display of the programmer.

In some embodiments, the patient remote or other external device incommunication with the IMD can be configured to collect variousobjective therapy metric data, such as that listed above, and implementan auto-titration algorithm that computes recommended therapy settingchanges for the IMD. The patient remote or other external device cancooperate with the IMD to modify the therapy settings using therecommended changes. In some embodiments, collection of objectivetherapy metric data, computing recommended therapy setting changes, andeffecting such changes in the IMD occur automatically, withoutintervention by the patient. In this regard, one or both of the patientremote/external device and the IMD can be configured to automaticallymake therapy setting changes to the IMD. The patient remote/externaldevice can subsequently collect the various objective therapy metricdata and assess the efficacy of the recommended therapy setting changes.The results of this efficacy assessment may be communicated to anexternal system and/or programmer, and the auto-titration process cancontinue to fine-tune the therapy setting changes.

The methodology illustrated in FIG. 9 further involves displaying 908 ona display of the programmer (and/or generating a report to include) thecurrent therapy settings, the one or more therapy settings modified bythe patient and optionally by the IMD, a previous state of the one ormore therapy settings modified by the patient and optionally by the IMD,the usage data, and optionally therapy effectiveness data. For example,the method may involve calculating times of delivered therapy per dayusing the usage data, and displaying or reporting the usage data mayinvolve displaying and/or reporting the therapy on time for each day (ora graphical representation thereof) over a predetermined duration oftime, such as at least a period of one week. Therapy effectiveness datacan be displayed or reported to indicate whether or not, and to whatextent, patient and optionally IMD changes to therapy settings hasimproved the patient's condition. An illustrative report showing thisinformation is provided in FIG. 22. The information shown in FIG. 22 isof a sleep log type that communicates the time and duration of therapyfor each day and therapy amplitude, and also includes compliance andnon-compliance information.

In some embodiments, the methodology shown in FIG. 9 may involveaccentuating 910 presentation of the one or more therapy settingsmodified by the patient relative to other therapy settings presented onthe display and/or in a report. In other embodiments, the therapysettings associated with the highest therapy compliance and/or besttherapy efficacy can be identified, and can be accentuated on thedisplay and/or in a report. In addition to displaying on the programmer,the therapy usage data can also be saved (e.g., in a report) for outputor download. Associating and displaying the various therapy settingswith usage and effectiveness data allows the clinician to modify therapysettings to maximize usage and effectiveness. For example, displayingusage data, associated therapy settings, and therapy efficacy datatogether (e.g., at the same location on the display) can facilitateclinician evaluation of and modifications to the therapy settings toenhance usage and effectiveness.

The methods disclosed herein may involve reporting informationconcerning patient and optionally by the IMD modification of therapysettings in a variety of different ways. For example, reporting patientmodification of one or more therapy settings may involve dispatching amessage or a report indicating patient modification of the one or moretherapy settings to a remote device. Some embodiments may involvegenerating control signals by a patient remote to effect modification ofone or more therapy settings of the IMD, and presenting information on adisplay of the patient remote or a device communicatively coupled to thepatient remote notifying the patient of the modification to the one ormore therapy settings. For example, the patient remote or devicecommunicatively coupled to the patient remote (e.g., cloud- orweb-mediated remote programming) may notify the patient to reviewparameter values based on the therapy parameter modifications made bythe patient (e.g., patient changes to amplitude, system flag amplitudelimit parameters).

Other embodiments may involve generating, at a patient remote configuredto communicatively couple to the IMD, a first control signal requestingmodification of one or more therapy settings of the IMD, performing oneor both of prompting the patient to confirm patient intent to modify theone or more therapy settings and recommending an alternativemodification to the one or more therapy setting, and generating, at thepatient remote, a second control signal to effect the requested oralternative modification to the one or more therapy settings. In someembodiments, prompting is implemented by the patient remote, while inother embodiments, prompting is implemented by a device communicativelycoupled to the patient remote (e.g., a smartphone running an appropriateapp).

According to some embodiments, various types of information abouttherapy setting changes made by the patient can be recorded by one orboth of the IMD and the patient remote, and this information can betransmitted to the clinician for evaluation. With reference to FIGS. 10and 11, a representative patient remote 1000 is configured to facilitatepatient adjustment of up to three different therapy parameters, shown asparameters A, B, and C. Parameter A may represent stimulation signalstrength or amplitude, parameter B may represent stimulation signalrate, and parameter C may represent stimulation signal pulse width.Reference is made to FIG. 12 which shows each of these representativeparameters (amplitude, rate, pulse width) superimposed on anillustrative stimulation waveform. According to various embodiments,stimulation amplitude is represented in terms of volts, and isconsidered the primary adjustment parameter made available to thepatient. Pulse width, which is the stimulation waveform duration, isrepresented in terms of microseconds, and is considered a secondaryadjustment parameter which affects the gross strength the stimulationenergy. Rate is represented in terms of pulses per second or Hertz, andis considered a secondary adjustment parameter which controls smoothnessof the stimulation sensation. It is noted that adequate airway patencyduring inspiration can be achieved for most patients by adjusting thestimulation amplitude only. In some embodiments, the patient ispermitted change only the stimulation amplitude setting. In otherembodiments, the patient may be permitted to change other parameters inaddition to stimulation amplitude, such as pulse width and rate, forexample.

It is understood that other stimulation signal parameters arecontemplated, and that the number and types of parameters alterable bythe patient as described herein are provided for illustrative purposesand not of limitation. In the representative embodiment shown in FIG.13, for example, a patient remote 1300 includes control buttons foradjusting a number of different therapy parameters. In this illustrativeexample, the patient remote 1300 includes an amplitude increase button510, and amplitude decrease button 512, a rate increase button 1302, arate decrease button 1304, a pulse width shorten button 1306, and apulse with lengthen button 1308. A control button 1310 is provided toallow selection between a number of different stimulation signalmorphologies, each of which has a different impact on the therapydelivered to the patient. For example, a first stimulation waveformversion may be characterized by a train of fixed duration pulses, whilea second stimulation waveform version may be characterized by a train offixed duration pulses interspersed with high-frequency short durationpulses.

Each of therapy parameters A, B, C shown in FIG. 10 has a number ofdifferent parameter settings or levels, L1-Ln, which can be individuallyselected by the patient. It is noted that the total number of parametersettings or levels for the different therapy parameters can be the sameor differ. As was discussed previously, the number and/or range ofpossible patient adjustable parameter settings are based at least inpart on the parameter range established by the clinician. In someembodiments, the clinician defines the number of different therapysetting levels as well as therapy setting increments between each level.In other embodiments, an algorithm can automatically determine thenumber of selectable therapy setting levels as well as the therapysetting increments between each level. For purposes of illustration, itcan be assumed that parameter A represents stimulation amplitude, andthat the stimulation strength controls 510 and 512 shown in FIG. 5A canbe used by the patient to increase and decrease the strength ofstimulation delivered by the IMD. The IMD may be programmed to defaultto a middle-strength amplitude, such as an amplitude corresponding tolevel L3. Pressing the stimulation increase button 510 causes thestimulation amplitude to increase in a step-wise fashion from anamplitude specified for level L3 to higher stimulation amplitude levels,such as L4, L5 or L6, for example. Pressing the stimulation decreasebutton 512 causes the stimulation amplitude to decrease in a step-wifefashion from an amplitude specified for level L3 to lower stimulationamplitude levels, such as L2 or L1, for example. The patient may adjustother parameters, such as parameters B and C, in a similar manner.

According to some embodiments, the amount or percentage of time eachtherapy parameter is active at each therapy level can be monitored andstored for subsequent assessment by the clinician. Reference is made toFIG. 11 which is a chart of representative information about each of thethree parameters A, B, and C that can be monitored, stored, andsubsequently evaluated by a clinician in accordance with variousembodiments. It is understood that the therapy parameter informationshown in FIG. 11 is provided for illustrative, non-limiting purposes.The information recorded in FIG. 11 includes the percentage or amount oftime the IMD delivered therapy at each of the specified parameter levelsare settings, L1-Ln. A trend or histogram of these data can be generatedand stored, allowing the clinician to evaluate changes that occur to thetherapy parameter settings over time, such as in a calendar-type manner.Storing a history of therapy parameter changes over a period of timeallows the clinician to apply various trending algorithms to the data.For example, the clinician may view the trend data to determine whetherthe therapy setting changes made by the patient fit a typical profile (apattern of progressive increases or decreases) or whether such changesare relatively random. If random, this may suggest that the patientrequires training or other form of intervention.

Other useful information may be associated with each of the differenttherapy parameters and parameter settings, such as various diagnosticindices. For example, an apnea-hypopnea index (AHI) and/or an oxygendesaturation index (ODI) can be associated with each setting or level(e.g., L1-Ln) of each therapy parameter (e.g., A-C). Other data, such assnorting (SI) data, nocturnal sound intensity, and nocturnal motiondata, can be collected and associated with each setting or level of eachtherapy parameter. Associating AHI and/or ODI or other diagnosticindices can provide additional information about the efficacy of apatient's therapy parameter adjustments. Therapy parameter and usagedata may be associated with objective therapy metrics, such as snoring,respiratory sonic data (e.g., sonic spectrographs), nocturnal motion,oximetry, and ODI/AHI, or subjective therapy metrics such as a sleepquestionnaire, for example. For example, ODI may be collected on thepatient remote, an AHI may be collected by the IMD (or by the patientremote using the microphone situated in proximity to the patient duringsleep), and quality of life (QOL) questionnaires may be implemented viaa web portal, a phone app, or on the patient remote itself. In someimplementations, one or more flags can be used to indicate when aparticular diagnostic index has exceeded a predetermined threshold. Theflag can be set by the IMD, the patient remote 1000, the programmer, ora combination of these devices.

Other useful information may also be associated with each of thedifferent therapy parameters and parameters, such as therapy usage andtherapy effectiveness. For example, the number of hours used per nightcan be associated with each setting or level.

FIGS. 14 and 15 show an embodiment of a neurostimulation apparatus inaccordance with various embodiments. The neurostimulation apparatusshown in FIG. 14 includes an implantable neurostimulator 1400electrically coupled to a stimulation lead 1410 having a stimulationelectrode 1405. The stimulation electrode 1405, which may be configuredas a cuff electrode, includes a number of electrodes, three of which areshown as electrodes 1420, 1422, and 1424 in the embodiment shown in FIG.14. The case or housing of the neurostimulator 1400 can serve as afar-field electrode in some configurations, but is typicallyelectrically inactive in a standard electrode configuration. FIG. 15shows the various electrode configurations or vectors that can beselected by the clinician and, in some embodiments, by the patient viathe patient remote (e.g., via the waveform version button 310 shown inFIG. 13 or a separate electrode configuration button). In accordancewith embodiments that allow patient selection of stimulation electrodeconfiguration, different combinations of electrodes can be activated anddeactivated by activation of an appropriate control button (e.g.,waveform version button 1310) on the patient remote.

FIG. 16 illustrates various activities associated with deliveringneurostimulation therapy for treating obstructive sleep apnea inaccordance with various embodiments. Using the patient remote, thepatient activates therapy 1602 prior to falling asleep, such as bypressing the therapy ON button 502 shown in FIG. 6. Activation of thetherapy ON button 502 initiates a start delay 1604. The patient mayverify that therapy is active by looking for illumination of the therapyON indicator 522 provided on the rear surface of the patient remote, asshown in FIG. 5B. The start delay 1604 (also referred to herein astherapy delay) represents a predetermined delay period (e.g., 30minutes) during which stimulation therapy is withheld or prevented,allowing the patient to fall asleep prior to actual delivery ofneurostimulation therapy, thus avoiding any discomfort associated withneurostimulation while not yet asleep.

After expiration of the start delay 1604, neurostimulation therapyautomatically turns on. The patient may pause 1608 therapy deliveryanytime during the night by pressing the therapy ON button 502 shown inFIG. 6, such as when awaking to use the bathroom. Therapy delivery ispaused for a predetermined duration of time, such as 15 minutes, toallow the patient to fall back asleep, after which therapy deliveryautomatically turns on. The total amount of pause time 1610 throughoutthe night is recorded, as is the total duration of the one or moretherapy active period(s) 1612. Stimulation therapy is terminated by oneof two events; either the patient presses the therapy OFF button 506shown in FIG. 5A or by expiration of the therapy duration timer, whichis typically set to a total duration of eight hours. The total durationof therapy delivered to the patient, which is an accumulation of alltherapy active periods 1606, 1612 during the evening, is calculated andstored. It is noted that the total duration of actual therapy deliveryis typically less than the total amount of time between initiation 1602and termination 1614 of therapy by the patient's use of the patientremote due to the start delay and one or more pause periods.

FIG. 17 is a screen 1700 of an application interface provided on adisplay of a programmer showing various therapy parameters of an IMD,such as a neurostimulator, that can be adjusted by a clinician inaccordance with various embodiments. In some embodiments, some or all ofthe therapy parameters are established by a clinician, and are input bythe clinician as initial therapy settings. In other embodiments, some orall of the initial therapy settings are predetermined as defaultsettings, which may subsequently be modified by the clinician.Establishing the initial therapy settings may involve usingpredetermined therapy settings based on patient population data,clinical trial research, and/or diagnostic information determined for aparticular patient.

The programmable parameters shown in FIG. 17 include an amplitudeparameter 1702, which is shown to have a value of 2.0 V in thisillustrative example. A patient control amplitude range 1704 is definedto include a lower limit and an upper limit, shown as 1.8 V and 2.8 Vrespectively in FIG. 17. In one embodiment, the lower and upper limitsof the patient control amplitude range 1704 are established by theclinician. In other embodiments, a functional threshold (FT) 1706 can bedefined by the clinician, which is used to automatically compute thelower and upper amplitude range limits 1704. For example, a processor ofthe programmer can compute the patient control amplitude range 1704using the formula FT+x volts (e.g., 1.0 V) divided by n steps (e.g., 11steps). In this illustrative example, the computed result is given by2.0 V+1.0 V=3 V/11=2.072. The lower and upper amplitude range limits1704 is computed as the programmed amplitude value (e.g., 2.0 V) −/+ thecomputed result (e.g., 2.07), which, when rounded, results in a range of1.8 V to 2.8 V, with 11 discrete voltage steps in between these twolimits. Accordingly, the patient remote can be used by the patient toadjust the clinician programmed amplitude within a range computed asdescribed above or established by the clinician, with 11 discretevoltage steps in between each adjustment within the establishedamplitude range.

Other therapy parameters that can be established by the clinicianinclude the electrode configuration 1710 which, in accordance with someembodiments, can be subsequently modified by the patient using thepatient remote as discussed previously. Various therapy timingparameters can be established by the clinician, including start delay1720 (e.g., 30 minutes), pause time 1722 (e.g., 15 minutes), and therapyduration 1724 (e.g., 8 hours). Various parameters associated with thestimulation waveform can be selected by the clinician, including pulsewidth 1730 (e.g., 90 μs), frequency 1732 (e.g., 33 Hz), and maximumstimulation time (e.g., 4 seconds). Other programmable therapyparameters include exhalation 1740 (e.g., −4/−1), inhalation 1742 (e.g.,0/+1), OFF period 1744 (e.g., 38/13), and signaling version 1750. Theexhalation parameters determine the detection of the start of exhalationphase of the respiratory cycle, whereas inhalation parameters determinethe detection of the start of inhalation phase of the respiratory cycle.The stimulation delivery is prohibited during the OFF period based onits programming.

FIG. 18 is a screen 1800 of an application interface showing varioustherapy settings on a display of a programmer in accordance with variousembodiments. The parameter screen 1800 includes patient identificationsection 1802, and actions section 1804, a report section 1806, a patientdetails section 1808, a patient therapy status section 1810, astimulation section 1830, and a sensing section 1860. The patientidentification section 1802 allows various information identifying thepatient be input and modified. The actions section 1804 allows forclinician actuation of various features, such as recording thresholds,adjusting stimulation parameters 1805, and adjusting sensing parameters.Various reports can be generated by actuation of one or more buttons inthe reports section 1806. Various patient details can be input,reviewed, and modified in the patient details section 1808.

The screen 1800 includes a number of parameters that impact patienttherapy status 1810, stimulation parameters 1830, and sensing parameters1860. The patient therapy section 1810 includes information concerningthe stimulation amplitude 1812 and any changes made thereto by thepatient, battery status 1818, and therapy usage 1820. A device therapysection (not shown) can be included for displaying informationconcerning various automated device-initiated changes made to therapysettings. Alternatively, the patient therapy section 1810 can displaypatient-initiated therapy changes in a manner that differs fromdevice-initiated therapy changes (e.g., different colors, different,fonts, indicia differentiating patient- from device-initiated therapychanges). In the embodiment shown in FIG. 18, a patient change to thestimulation amplitude 1812 is reflected by presentation of the currentstate of the amplitude selected by the patient (2.2 V) followed bypresentation of the previous state of the amplitude (2.3 V). Anindicator 1816, such as a “patient made change” indicator, is presentedon the screen 1800 next to the amplitude change information so as toalert the clinician to the change in stimulation amplitude made by thepatient. A different indicator 1817 can be presented to indicate nochange was made by the patient. In general, the change in stimulationamplitude or other therapy parameter modified by the patient isaccentuated in some way so as to call attention to the change when theclinician accesses this information on the screen 1800. This changeinformation can be accentuated in a number of ways, such as by a changein font, bolding, underlining, coloring, and/or the addition ofgraphical or textual indicia (e.g., message 1816). An audio message orsound can also be broadcast to draw clinician attention to a programmingchange made by the patient.

The stimulation section 1830 includes changes made by the clinician tovarious stimulations therapy settings during a patient visit. In theillustrative example shown in FIG. 18, the encircled region indicatesthe stimulation parameters that have been changed by the clinicianduring the current programming session, which include the stimulationamplitude 1832 (changed from 2.3 V to 2.0 V). The patient control range1834 is also accentuated to show changes made thereto. As was previouslydiscussed, the patient control range 1834 can be established manually orvia an algorithm executed by a processor of the programmer. Otherstimulation parameters include start delay 1835, pause time 1836, andtherapy duration 1838.

FIG. 19 shows various settings that can be adjusted from the adjuststimulation section 1805 (see also FIG. 18). The adjust stimulationsection 1805 allows the clinician to adjust the stimulation amplitude1830, various timing parameters 1910, and enable or disable control 1902of the stimulation amplitude by the patient remote. When control 1902 ofstimulation amplitude is enabled, the lower limit 1904 and upper limit1906 can be adjusted manually or algorithmically as previouslydiscussed. In general, and for established patients, the therapeuticamplitude control limits 1904 and 1906 are generally set to steps belowand above the patient's titrated stimulation amplitude. Any change ineither the upper or lower limits 1904 in 1906 from a previous setting isaccentuated for each of the lower and upper limits 1904 and 1906 (e.g.,a reduction of 0.3 V in the lower limit and an increase of 0.4 V in theupper limit is indicated by the gray colored text in parentheses).

FIGS. 20 and 21 illustrates therapy parameter information that can begenerated by a programmer including the initial and final states oftherapy setting that have been modified during a multiplicity oftime-separated programming sessions in accordance with variousembodiments. In some embodiments, programming of an IMD for a particularpatient occurs during each of a multiplicity of individual programmingsessions that extend over a given period of time, such as during anevening. During each individual programming session, one or more therapyparameters can be modified by the clinician. Although it may be possibleto generate a report concerning the initial and final states of therapysettings for each individual programming session, therapy settingchanges that occur across several time-separated programming session aretypically not accounted for nor easily determinable by the clinician. Asa result, a clinician is typically required to evaluate each report fromeach individual programming session, and manually determine which, ifany, therapy settings have changed from one session to another so thatthe initial and final states of all modified therapy settings over thecourse of the entire programming session can be determined.

Embodiments of the present disclosure are directed to a programmerconfigured to generate a summary report based on programming thatoccurred during a multiplicity of programming sessions. Variousembodiments are directed to a method of programming an IMD, such as aneurostimulator, using a wireless mobile programmer or other type ofprogrammer during each of a plurality of time-separated programmingsessions comprising at least a first programming session and a lastprogramming session. The method involves establishing initial therapysettings of the IMD during the first programming session, modifying oneor more of the therapy settings during one or more programming sessionsubsequent to the first programming session, and generating a summarybased on programming that occurred during the programming sessions.According to some embodiments, the summary comprises a current state ofany therapy setting that remained unchanged between the first and lastprogramming sessions, a final state of any therapy setting that wasmodified between the first and last programming sessions, and initialstate of any therapy setting that was modified between the first andlast programming sessions. The method further involves presenting thesummary on a display of the programmer or other output device or media.

According to some embodiments, generating the summary involvesgenerating a session summary for each programming session. The sessionsummary can include an indication of final therapy settings for eachprogramming session that were unchanged during the programming session,and an indication of an initial state of any final therapy setting thatwas modified during each programming session. The method furtherinvolves presenting the session summaries on the display or other outputdevice or media. In some embodiments, presenting the summary involvesaccentuating presentation of the final state and/or the initial state ofany therapy setting that was modified between the first and lastprogramming sessions. Some embodiments involve determining an aggregateduration of the multiplicity of time-separated programming sessions, andpresenting the aggregate duration on the display or other output deviceor media. For example, the method may involve determining a duration ofeach of the plurality of time-separated programming sessions,determining an aggregate duration of the plurality of time-separatedprogramming sessions, and presenting the duration and aggregate durationon the display or other output device or media.

FIG. 20 is a screen 2000 of an application interface showing informationconcerning a multiplicity of programming sessions conducted over thecourse of a single day (or night) in accordance with variousembodiments. The particulars of each individual programming session canbe reviewed by the clinician clicking on a given programming sessionunder the Reports tab 2002. In this illustrative embodiment, theprogramming session reports under the Report tab 2002 containinformation about each of a multiplicity of time-separated programmingsessions of a patient's sleep study conducted over the course of anevening. Modifications to various therapy settings that occurred duringthe programming session highlighted as session 2003 are summarized inthe stimulation section 2004. During the programming session 2003, thestimulation amplitude was changed by the clinician from 2.3 V to 2.2 V,and the patient control range was changed from 2.0-2.7 V to 2.0-2.4 V.Similar changes may have occurred during each of the other programmingsessions shown under the Reports tab 2002.

FIG. 21 is a screen 2100 of an application interface showing a summaryreport that provides a clear indication of the initial and final statesof any therapy setting that was modified between the first and lastprogramming sessions of a multi-programming session sleep study inaccordance with various embodiments. The therapy setting changes madeover the course of multiple programming sessions shown in FIG. 20 aresummarized under the tab 2102 entitled 12 Mar 14. It can be seen undertab 2102 (for 12 Mar 14) that the amplitude was changed from an initialstate of 2.3 V to a final state of 2.2 V sometime during the multipleprogramming session event. It can also be seen that that patient controlrange was changed from an initial state of 2.0-2.7 V to a final state of2.2-2.4V sometime during the multiple programming session event. Thechanged state of these therapy parameters is accentuated by a check markindicator in this illustrative example. It is noted that other data forother programming days/nights has been excluded for purposes ofsimplicity of explanation.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations can besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present disclosure. This application isintended to cover any adaptations or variations of the specificembodiments discussed herein. Therefore, it is intended that thisdisclosure be limited only by the claims and the equivalents thereof.

What is claimed is:
 1. A method, comprising: receiving, at a clinicianprogrammer, therapy settings data indicative of current therapy settingsoperative in an implantable medical device configured to deliverneurostimulation therapy and any modifications made to the therapysettings by a patient via a patient remote; determining, by theclinician programmer, if one or more therapy settings have been modifiedby the patient; displaying, on a display of the clinician programmer,the current therapy settings, the one or more therapy settings modifiedby the patient, and a previous state of the one or more therapy settingsmodified by the patient; determining if a duration of therapy deliveredto the patient over a specified span of time indicates compliance ornon-compliance with a therapy regimen for the patient; and displaying anindication of compliance or non-compliance with the therapy regimen onthe display.
 2. The method of claim 1, wherein displaying comprisesaccentuating presentation of the one or more therapy settings modifiedby the patient relative to other therapy settings presented on thedisplay.
 3. The method of claim 1, wherein displaying comprisesaccentuating presentation of the previous state of the one or moretherapy settings modified by the patient and the one or more therapysettings modified by the patient relative to other therapy settingspresented on the display.
 4. The method of claim 1, further comprisingdetermining if one or more therapy settings have been modified by thepatient or automatically.
 5. The method of claim 1, further comprising:determining if one or more therapy settings have been modified by thepatient or automatically; and accentuating presentation of the therapysettings and their respective previous state differently depending onwhether therapy settings were modified by the patient or automatically.6. The method of claim 1, further comprising generating a reportindicating patient modification of the one or more therapy settings. 7.The method of claim 1, further comprising dispatching a message or areport indicating patient modification of the one or more therapysettings to the patient remote.
 8. The method of claim 1, wherein theclinician programmer is configured to communicate with the patientremote comprising a display, the method further comprising: generating,by the patient remote, control signals to effect modification of one ormore therapy settings of the implantable medical device; and presentinginformation on the display of the patient remote or a devicecommunicatively coupled to the patient remote notifying the patient ofthe modification to the one or more therapy settings.
 9. The method ofclaim 1, wherein the clinician programmer is configured to communicatewith the patient remote comprising a display, the method furthercomprising: generating, by the patient remote, a first control signalrequesting modification of one or more therapy settings of theimplantable medical device; performing, by the patient remote, one orboth of prompting the patient to confirm patient intent to modify theone or more therapy settings and to recommend an alternativemodification to the one or more therapy setting; and generating, by thepatient remote, a second control signal to effect the requested oralternative modification to the one or more therapy settings.
 10. Themethod of claim 1, wherein: the implantable medical device is aneurostimulation device configured to deliver a neurostimulation therapyfor treating an obstructive disordered breathing condition of thepatient; and the therapy settings data comprises data about one or moretherapy parameters that affect delivery of the neurostimulation therapy.11. The method of claim 1, further comprising wirelessly receiving, bythe clinician programmer, the therapy setting data via a communicationpath that comprises one or more wireless communication links between theclinician programmer and the implantable medical device.
 12. A method,comprising: receiving, at a clinician programmer, therapy settings dataindicative of current therapy settings operative in an implantablemedical device configured to deliver neurostimulation therapy and anymodifications made to the therapy settings by a patient via a patientremote; determining, by the clinician programmer, if one or more therapysettings have been modified by the patient; acquiring usage dataindicating a duration of therapy delivered to the patient over aspecified span of time; displaying, on a display of the clinicianprogrammer, the current therapy settings, the one or more therapysettings modified by the patient, a previous state of the one or moretherapy settings modified by the patient, and the usage data;determining if the duration of therapy delivered to the patient over thespecified span of time indicates compliance or non-compliance with atherapy regimen for the patient; and displaying an indication ofcompliance or non-compliance with the therapy regimen on the display.13. The method of claim 12, further comprising determining, by theclinician programmer, if one or more therapy settings have been modifiedby the patient or automatically.
 14. The method of claim 12, furthercomprising: calculating times of delivered therapy per day using theusage data; and displaying textually or graphically the therapy deliverytime for each day over at least a period of one week on the display. 15.The method of claim 12, further comprising: determining effectiveness ofthe therapy setting modifications made by the patient; and displayingeffectiveness data on the display.
 16. The method of claim 12, whereinthe specified span of time is defined by a duration of time between aprevious acquisition of usage data and a current acquisition of usagedata.
 17. The method of claim 12, further comprising: calculating anumber of hours of delivered therapy per week using the usage data; anddisplaying the calculated number of hours of delivered therapy per weekon the display.
 18. The method of claim 12, further comprising:calculating times of delivered therapy per day using the usage data; anddisplaying textually or graphically the therapy delivery time for eachday over at least a period of one week on the display.
 19. The method ofclaim 12, further comprising: determining battery status of theimplantable medical device; displaying battery status on the display ofthe clinician programmer in proximity to the usage data; and predictingbattery longevity based at least in part on the usage data and therapysettings.